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Adalimumab Intralesional in Intestinal Strictures of Crohn's Disease Patients

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ClinicalTrials.gov Identifier: NCT01986127
Recruitment Status : Recruiting
First Posted : November 18, 2013
Last Update Posted : March 29, 2017
Hospital Clinic of Barcelona
Information provided by (Responsible Party):
Sara Varea, Fundació Clínic per la Recerca Biomèdica

Brief Summary:
We study if the administration of intralesional Adalimumab (directly injected in the stricture) associated to endoscopic dilatation has a higher success rate at week 8 compared with placebo in patients with Crohn's disease who had confirmed intestinal stenosis (3 stenosis as maximum)

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: Adalimumab Drug: placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blinded, Placebo-controlled Study on the Effects of Adalimumab Intralesional Intestinal Strictures of Crohn's Disease Patients
Study Start Date : February 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Adalimumab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Adalimumab
single administration of Adalimumab 80mg diluted in 5ml saline
Drug: Adalimumab
single intralesional administration during endoscopy process
Placebo Comparator: saline
5 ml of saline
Drug: placebo
single intralesional administration during endoscopy

Primary Outcome Measures :
  1. Success of endoscopic dilatation [ Time Frame: at week 8 ]
    Successful dilatation means the passage of the endoscope (or enteroscopy colonoscope) through the stenosis

Secondary Outcome Measures :
  1. Stenosis measure [ Time Frame: baseline ]
    The endoscopic stenosis diameter will be estimated pre and post-dilatation

  2. success of endoscopic dilatation [ Time Frame: at week 52 ]
    The success of endoscopic dilatation at week 52 means absence of clinical subocclusion, no necessity of surgical nor endoscopic dilatation

  3. Mucosal healing [ Time Frame: at week 8 ]
    • Anastomotic strictures: We define mucosal healing as a Rutgeerts < or equal 2 with at least 1 point of improvement (añadir el score)
    • Primary strictures: Absence of ulcers after treatment

  4. Histological cure [ Time Frame: at week 8 ]

    We consider histological cure if:

    • Epithelial damage is < or equal 1
    • Architectural changes is < or equal 1
    • Infiltration of mononuclear cells in lamina propria is < or equal 1
    • Polymorphonuclear cells in the lamina propria = 0
    • Polymorphonuclear cells in epithelium = 0
    • Absence of erosions and ulcers (based ib scoring system for Histologic Abnormalities in Crohn's disease Mucosal Biopsy Specimens - Title: Early lesions of recurrent Crohn's disease caused by infusion of intestinal contents in excluded ileum Author(s): D'Haens, Geert R.; Geboes, Karel; Peeters, Mark; et al. Source: Gastroenterology Volume: 114 Issue: 2 Pages: 262-267 Published: Feb., 1998)

  5. proportion of patients that develop anti-adalimumab antibodies [ Time Frame: at the end of the study ]
  6. adverse events [ Time Frame: at the end of the study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients of both sexes older than 18 years
  • Patient diagnosed of CROHN´s disease
  • Patient with intestinal stenosis length equal or less than 5cm previously confirmed with bowel magnetic resonance imaging (3 stenosis as maximum)
  • Stenosis no permeable for endoscopy(12mm in case of accessible stenosis with conventional colonoscopy and 10mm in case of accessible stenosis with balloon enteroscopy)
  • Dilated stenosis according to endoscopist criteria (pass or no the endoscopy)
  • Patient capable of participate in the examinations required by the study
  • Patient after being informed, give his/her informed consent in writing

Exclusion Criteria:

  • Patients with large intestinal stenosis (more than 6cm) and multiples
  • Patients with previous or actual treatment with anti-tumor necrosis factor (anti-TNF) drugs
  • Patients with positive serology to hepatitis B virus(HBV),hepatitis C virus (HCV), or HIV
  • Patients with positive screening to Tuberculosis(positive PPD)
  • Established contraindication to anti-TNF drugs
  • Existence of fistulous tracts associated with intestinal stenosis
  • Neoplastic process associated with stenosis or in another location
  • Pregnancy or breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01986127

Contact: Begoña Gonzalez Suarez, MD BGONZALS@CLINIC.UB.ES
Contact: Sara Varea Latorre, BSc svarea@clinic.ub.es

Complexo Hospitalario Arquitecto Marcide -Novoa Santos Recruiting
Ferrol, A Coruña, Spain, 15405
Contact: Ana Echarri, MD       ana.echarri.piudo@sergas.es   
Principal Investigator: Ana Echarri, MD         
Complexo Hospitalario Universitario de Santiago Active, not recruiting
Santiago de Compostela, A Coruña, Spain, 15706
Hospital Parc Taulí Not yet recruiting
Sabadell, Barcelona, Spain, 08208
Contact: Enric Brullet, MD       ebrullet@tauli.cat   
Principal Investigator: Enric Brullet, MD         
Hospital Moises Broggi Active, not recruiting
Sant Joan Despí, Barcelona, Spain, 08970
Hospital Mutua de Terrassa Active, not recruiting
Terrassa, Barcelona, Spain, 08221
Hospital Universitario Puerta del Hierro Active, not recruiting
Majadahonda, Madrid, Spain, 28222
Hospital Universitari Son Espases Active, not recruiting
Palma de Mallorca, Mallorca, Spain, 07120
Hospital General Universitario de Alicante Active, not recruiting
Alicante, Spain, 03010
Hospital Clinic of Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Begoña Gonzalez Suarez, MD       BGONZALS@clinic.ub.es   
Principal Investigator: Begoña Gonzalez Suarez, MD         
Hospital del Mar Active, not recruiting
Barcelona, Spain
Complejo asistencial universitario de Burgos Active, not recruiting
Burgos, Spain, 09005
Hospital Josep Trueta Active, not recruiting
Girona, Spain, 17007
Hospital La Paz Active, not recruiting
Madrid, Spain, 28046
Hospital La Fe Active, not recruiting
Valencia, Spain, 46026
Sponsors and Collaborators
Sara Varea
Hospital Clinic of Barcelona
Principal Investigator: Begoña González Suarez, MD Hospital Clinic of Barcelona
Principal Investigator: Lucía Márquez, MD Hospital del Mar
Principal Investigator: Alfredo Mata, MD Hospital de Sant Joan Despí Moisès Broggi
Principal Investigator: Carlos Huertas, MD Hospital Josep Trueta
Principal Investigator: Lidia Argüello, MD Hospital La Fe
Principal Investigator: Enric Brullet, MD Hospital Parc Taulí
Principal Investigator: Cecilia González, MD Hospital Gregorio Marañón
Principal Investigator: Ana Echarri, MD Complexo Hospitalario Arquitecto Marcide-Novoa Santos
Principal Investigator: Carme Loras Hospital Mútua Terrassa
Principal Investigator: Maria D Martín Arranz Hospital Universitario La Paz
Principal Investigator: Manuel Barreiro Complexo Hospitalario de Santiago
Principal Investigator: Yago González Hospital Universitario Puerta del Hierro
Principal Investigator: Beatriz Sicília Complejo asistencial Universitario de Burgos
Principal Investigator: Sam Korrhami Hospital Son Espases
Principal Investigator: Ana Gutiérrez Hospital General Universitario de Alicante

Responsible Party: Sara Varea, Clinical Research Manager, Fundació Clínic per la Recerca Biomèdica
ClinicalTrials.gov Identifier: NCT01986127     History of Changes
Other Study ID Numbers: CSAI
2012-001723-12 ( EudraCT Number )
First Posted: November 18, 2013    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017

Keywords provided by Sara Varea, Fundació Clínic per la Recerca Biomèdica:
Crohn disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Anti-Inflammatory Agents
Antirheumatic Agents